Ticagrelor is the active ingredient in the drug product known as BRILINTA® (or BRILIQUE in Europe) which has been approved for use in multiple jurisdictions including the USA and Europe. Ticagrelor is disclosed as an ADP-receptor antagonist in International Patent Application number PCT/SE99/02256 (publication number WO 00/34283). The discovery of ticagrelor is discussed in Humphries B., et al., “‘Daring to be Different’: the Discovery of Ticagrelor”, The Handbook of Medicinal Chemistry, Principles and Practice, 2015, The Royal Society of Chemistry, UK; and Springthorpe B., et al., Biorg. Med. Chem. Lett. 17 (2007) 6013-6018.
BRILINTA® is currently marketed in the form of 60 mg and 90 mg immediate release tablets. International Patent Application number PCT/SE2007/000736 (publication number WO 2008/024045) discloses certain pharmaceutical formulations containing ticagrelor for oral administration.
A significant proportion of patients with stroke have difficulty swallowing (dysphagia) in the acute phase, and many have ongoing problems. This potentially can lead to a reduction in patient compliance when such patients are administered oral formulations that must be swallowed intact. Other patients may also suffer from dysphagia as it is common among all age groups and is observed in about 35% of the general population, as well as up to 60% of the elderly institutionalized population and about 20% of all patients in long-term care facilities.
The present invention relates to alternative ticagrelor dosage forms that can be administered, for example, to such patients. These dosage forms are rapidly disintegrating oral dosage forms containing ticagrelor, including such dosage forms that produce a ticagrelor bioavailability substantially comparable to the currently marketed 60 mg or 90 mg immediate release dosage forms.
The listing or discussion of a prior-published document in this specification should not necessarily be taken as an acknowledgement that the document is part of the state of the art or is common general knowledge.